Study of an Experimental Drug Delivery System in the treatment of subjects with Macular Edema following Central Retinal Vein Occlusion or Branch Retinal Vein Occlusion

Sponsored by Allergan, Inc.

Study Summary

Dr. Lawrence Ulanski of The University of Illinois at Chicago is conducting a study to determine the safety and effectiveness of an experimental drug delivery system. This drug delivery system is used to place the steroid-like drug into the back of the eye. You may be able to participate in this research study if you have macular edema, which is swelling of the macula, due to central retinal vein occlusion or branch retinal vein occlusion. The retina is the light-sensitive tissue at the back of your eye. The macula is a tiny oval area located at the center of the retina that is responsible for your central vision, and is essential for tasks requiring detailed vision, such as reading. Macular edema is a build up of fluid causing swelling in the macula resulting in reduced central vision.

Dexamethasone is a U.S. Food and Drug Administration (FDA) and Health Canada approved steroid available in eye drops for treating various eye conditions. Dexamethasone has been shown to prevent swelling and suppress inflammation in previous studies of retinal disorders, including macular edema. In past studies, dexamethasone was used as a single injection into the eye. However, the use of dexamethasone has yielded limited success in treating macular edema, largely due to the inability to deliver and maintain adequate quantities of the drug to produce effective results. This experimental drug delivery system s lowly releases dexamethasone over time. The researchers hope that this system will deliver dexamethasone so that the necessary concentration of the drug is sustained in the eye.

If you participate in this study, you may receive no direct benefit. However, the possible benefits for other people with this condition may include more information about macular edema due to central retinal vein occlusion or branch retinal vein occlusion and the development of future treatments.

If you qualify and agree to participate, you will be assigned randomly by chance (similar to tossing a coin) to one of 3 procedures. You will receive one of the following: 700 μg drug dose; 350 μg drug dose; or a sham procedure (the sham procedure does not contain any study medication). After the end of 6 months, regardless of the treatment you first received, you will receive treatment with the 700 μg DEX PS DDS Applicator System in your study eye UNLESS your visual acuity has improved to normal (20/20 vision or better) AND the macular edema is gone or nearly gone, OR your study doctor feels the procedure would put you at risk. You will continue to be followed for an additional 6 months even if you do not receive the 700 μg DEX PS DDS treatment at Month 6.

Participants are expected to be in the study for about 12 months. There will be a total of up to 14 visits. Subjects will be paid $40 per visit for participation in this study.

Participation Criteria

To be considered for enrollment in this study, you must:

• Be at least 18 years of age

• Give written informed consent

• Have macular edema due to central retinal vein occlusion or branch retinal vein occlusion

• Be willing to undergo a procedure for insertion of the experimental drug delivery system or undergo a sham procedure which mimics an actual injection

• Be available for study visits for the duration of the study

• Not be pregnant, breastfeeding, or planning a pregnancy at any time during the study

• Be able to understand and follow the study instructions

• Not have participated in an investigational drug or device study within the 30 days prior to study enrollment

• Meet all study eligibility criteria as evaluated by Dr. Ulanski

Principal Investigator: Lawrence Ulanski, MD

Department: Ophthalmology